nepafenac
Trade name: nevanac
Small moleculeapproved
Approved
Aug 19, 2005
Nepafenac is a non-steroidal anti-inflammatory prodrug (NSAID) usually sold as a prescription eye drop. Nepafenac is manufactured by Alcon and sold under the trade name Nevanac. It is used to treat pain and inflammation associated with cataract surgery. After penetrating the cornea, nepafenac undergoes rapid bioactivation to amfenac, which is a potent NSAID that uniformly inhibits the COX1 and COX2 activity. — NCATS
Clinical trial activity
55 trials · 49 clinical orgs · 3 marketing orgs
Phase 1
0
Phase 2
22
Phase 3
12
Phase 4
24
Earliest trial started Sep 1, 2005 (NCT00333255)
Timeline
2000s
- Jan 1, 2005
- Aug 19, 2005
Alcon — Earliest FDA Approval
- Aug 19, 2005
Alcon — NDA Organization
- Aug 19, 2005
Novartis — NDA Secondary Org
- Aug 19, 2005
Novartis — Marketing Organization
- Aug 19, 2005
Harrow Health — Marketing Organization
- Aug 19, 2005
Harrow Health — NDA Secondary Org
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Cataract · Phase 4
- Conjunctivitis, Bacterial · Phase 2
- Corneal Endothelial Cell Loss · Phase 2
- Diabetic Retinopathy · Phase 3
- Endothelium · Phase 4
- Epiretinal Membrane · Phase 4
- General Surgery · Phase 4
- Hyperopia · Phase 4
- Intraocular Pressure · Phase 4
- Macula Lutea · Phase 2
- Macular Degeneration · Phase 4
- Macular Edema · Phase 4
- Miosis · Phase 2
- Myopia · Phase 4
- Pain · Phase 4
- Photorefractive Keratectomy · Phase 4
- Pseudophakia · Phase 4
- Retinal Diseases · Phase 4
- Retinal Vein Occlusion · Phase 4
- Uveitis · Phase 4
- Vitrectomy · Phase 4
- Vitreoretinopathy, Proliferative · Phase 4
Mechanism of action
- CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
Approval history
- approvedPriority reviewAug 19, 2005
Chemistry & pharmacology
Loading structure…
SMILES
NC(=O)CC1=C(N)C(=CC=C1)C(=O)C2=CC=CC=C2- Mol. weight
- 254.2839 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Prodrug
Sources
- WikipediaNepafenac ↗
- NCATS0J9L7J6V8C ↗
- ChEMBLCHEMBL1021 ↗
Also known as
- 2-amino-3-benzoylbenzeneacetamide
- 2-amino-3-benzoylbenzeneacetamide
- 2-amino-3-benzoylbenzeneacetamide
- ahr 9434
- ahr 9434
- ahr-9434
- ahr-9434
- al 6515
- al 6515
- al-6515
- al-6515
- al-6515
- amfenac amide
- amfenac amide
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenac
- nepafenaco
- nepafenaco
- nepafenacum
- nepafenacum
- nevanac
- nevanac
- nevanac
- nevanac
- nevanac
- nevanac
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07178639 | N/A | Aug 1, 2025 | Nemocnice Kolín |
| NCT05331690 | Phase 4 | Nov 25, 2022 | University of Oslo |
| NCT05542381 | N/A | Oct 1, 2022 | Virginia Polytechnic Institute and State University |
| NCT05072262 | Phase 4 | Oct 31, 2021 | University of Oslo |
| NCT07162818 | Phase 4 | Apr 28, 2021 | University of Indonesia |
| NCT04843839 | Phase 2 | Dec 15, 2020 | Allergan, L. V. Prasad Eye Institute |
| NCT03851172 | Phase 2 | Mar 1, 2019 | Assiut University |
| NCT03918590 | Phase 4 | Dec 3, 2018 | The New York Eye & Ear Infirmary |
| NCT03597867 | Phase 3 | Apr 25, 2018 | University of Trieste |
| NCT03499873 | Phase 3 | Mar 28, 2018 | Actavis |
| NCT03496467 | Phase 2 | Mar 5, 2018 | Mati Therapeutics Inc. |
| NCT01939691 | Phase 4 | Dec 1, 2017 | University of California, San Francisco |
| NCT03406689 | N/A | Sep 1, 2017 | University of Patras |
| NCT02955641 | N/A | Nov 1, 2016 | Tel Aviv University |
| NCT02821390 | N/A | Jun 1, 2016 | University of Patras |
| NCT02752646 | N/A | Apr 1, 2016 | Alcon, MDbackline, LLC, University of California, Los Angeles |
| NCT02506348 | N/A | Jul 1, 2015 | Tel Aviv University |
| NCT02515045 | Phase 4 | Jan 1, 2015 | Carolina Eyecare Physicians, LLC, Science in Vision |
| NCT02361645 | Phase 3 | Mar 1, 2014 | University of Brescia |
| NCT01657266 | Phase 2 | Dec 1, 2013 | Laboratorios Sophia S.A de C.V. |
Showing 20 of 55 trials
Page 1 / 3
Organizations
Research & Development (49)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alcon | For profit | 14 | 13 | 4 | 2005 |
| Allergan | For profit | 4 | 0 | 2 | 2006 |
| Bausch & Lomb | For profit | 3 | 0 | 2 | 2010 |
| Innovative Medical Research of South Florida, Inc | For profit | 3 | 3 | 1 | 2006 |
| Bucci Laser Vision Institute | Academic/Hospital | 2 | 2 | 1 | 2009 |
| Center For Excellence In Eye Care | Academic/Hospital | 2 | 1 | 1 | 2006 |
| Discover Vision Centers | Academic/Hospital | 2 | 1 | 2 | 2010 |
| Tel Aviv University | Academic/Hospital | 2 | 2 | 1 | 2015 |
| University of Oslo | Academic/Hospital | 2 | 2 | 1 | 2021 |
| University of Patras | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Actavis | For profit | 1 | 1 | 1 | 2018 |
| Arizona Eye Consultants | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Asociación para Evitar la Ceguera en México | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Assiut University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Bp Consulting, Inc | For profit | 1 | 1 | 1 | 2009 |
| Carolina Eyecare Physicians, LLC | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Churchhill Communications | For profit | 1 | 0 | 1 | 2013 |
| Clinica Oftamologica Zona Sul | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Coburn-Kleinfeldt Eye Clinic | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Dr T V Patel Eye Institute | Academic/Hospital | 1 | 1 | 1 | 2012 |
49 organizations
Page 1 / 3
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alcon | For profit | NDA | Aug 19, 2005 |
| Harrow Health | For profit | MKTG | Aug 19, 2005 |
| Harrow Health | For profit | NDA2 | Aug 19, 2005 |
| Novartis | For profit | NDA2 | Aug 19, 2005 |
| Novartis | For profit | MKTG | Aug 19, 2005 |